Persistent Pain After Breast Cancer Treatment With Docetaxel

Breast cancer treatment is for many patients followed by sequelae, such as persistent pain, sensory disturbances, lymphedema and reduced physical function. These undesired consequences of the treatment are a major clinical problem, with persistent pain affecting 25-60%, sensory disturbances 20-80%, lymphedema 2-86% and reduced physical function 13-28% of patients. Development of persistent pain after breast cancer treatment, involves a complex pathophysiology that involves pre-, intra- and postoperative factors. Several risk factors for the development of persistent pain after breast cancer treatment have been identified; young age, psychosocial factors, surgical procedure and radiation therapy. Neurotoxicity is a well know attribute of many chemotherapeutic agents, such as taxanes. The purpose of this nationwide study is to retrospectively examine a cohort of breast cancer patients treated with docetaxel, to clarify if docetaxel may influence the prevalence and intensity of persistent pain and other sequelae.

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Key information

Conditions

Breast Neoplasms Breast Diseases Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasms Neoplasms by Site Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Postoperative Complications Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Treated for primary breast cancer in Denmark 2007-2008
Age between 18-80 years
No recurrent cancer
Female

Exclusion criteria

Previous breast surgery same side (including plastic and reconstructive surgery)
Bilateral breast surgery
Recurrent cancer or metastatic cancer

Treatment and study plan

Primary outcomes

Docetaxel as a risk factor for development of persistent pain

Time frame: Between 2-3 years post surgery

Secondary outcomes

Prevalence of persistent pain, sensory disturbances, lymphedema and functional limitations

Time frame: Between 2-3 years post surgery

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Jan 19, 2011
Registry last updated: Jan 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed